Cassava Sciences Reports Full-year 2022 Financial Results and Operating Updates
- In Q2 2023, We Expect to Complete Patient Dosing for our Cognition Maintenance Study in Alzheimer’s disease.
- In Q3 2023, We Expect to Announce Results of our Cognition Maintenance Study.
- In Q4 2023, We Expect to Complete Patient Enrollment for our Phase 3 Studies of Simufilam in Alzheimer’s disease.
- Mid-year 2023, We Expect an
Independent Third Partyto Present Evidential Data for The Biological Activity of Simufilam Outside of Neurodegeneration.
- Cash And Cash Equivalents Were
$201 Millionat December 31, 2022.
“Setting aside headwinds, 2022 was highlighted by positive developments with patient enrollment in our Phase 3 clinical studies of simufilam in Alzheimer’s disease”, said
Alzheimer’s disease is a major public health issue. It imposes an immense burden on patients, their families and caregivers. Anti-amyloid antibody drugs that have received FDA approval are a step in the right direction. But by themselves, anti-amyloid drugs may not be enough for patients. Anti-amyloid drugs can slow cognitive decline modestly, but they can also cause brain bleeds in elderly patients, they require monthly trips to the local infusion center and periodical monitoring with MRI, they’re expensive and they lack Medicare coverage because they bypassed the full FDA approval process. Patients have waited many years for anti-amyloid drugs to be FDA-approved. Now that the wait is over,
“It’s the spirit of innovation and our intense desire to help patients and their families that fuels our drive to develop simufilam as an oral drug candidate for people with Alzheimer’s disease,” said
Cassava Sciences’ Scientific Goals for 2023
- In Q2 2023, we expect to complete patient dosing for our on-going Cognition Maintenance Study, in which over 100 patients with mild-to-moderate Alzheimer’s disease are randomized (1:1) to simufilam or placebo for six months.
- In Q3 2023, we expect to announce top-line results of the Cognition Maintenance Study.
- In Q4 2023, we expect to complete patient enrollment for both of our Phase 3 studies.
- Mid-year 2023, we expect an independent, third party to present evidential data for the biological activity of simufilam outside the field of neurodegeneration.
- Mid-year 2023, we expect an independent, third party to generate new data for SavaDx using mass spectrometry.
December 31, 2022, cash and cash equivalents were $201 million, compared to $233.4 millionat December 31, 2021, with no debt. Year-end cash balance included net proceeds of $47.3 millionfrom the sale of 1.7 million shares of common stock completed in November 2022.
- Net cash used in operations full-year 2022 was
$77.5 million, net of reimbursements received from National Institutes of Health(NIH) grant awards.
- Net cash use for operations for the first half of 2023 is expected to be approximately
$45to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.
- Research and development (R&D) expenses for the year ended
December 31, 2022were $68.0 millioncompared to $24.8 millionfor the same period in 2021. This increase was due primarily to costs to conduct the ongoing Phase 3 clinical program in simufilam, costs of an ongoing cognition maintenance study and open-label study in simufilam, and costs related to manufacture of clinical trial supplies, as well as increased pre-clinical study and personnel expenses compared to the prior year. These expenses are net of grant funding received from NIH, which is recorded as a reduction in R&D expenses.
- Research grant funding reimbursements of
$0.9 millionwere received from NIHand recorded as a reduction in R&D expenses. This compared to $3.9 millionof NIHgrant receipts received for 2021.
- General and administrative (G&A) expenses for the year ended
December 31, 2022were $12.0 millioncompared to $8.1 millionfor 2021. This increase was primarily due to higher legal fees, personnel costs, insurance costs and depreciation and amortization as compared to 2021.
Ongoing Phase 3 Studies with Simufilam
Simufilam (sim-uh-FILL-am) is the chemical name for Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain.
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Cautionary Note Regarding Forward-Looking Statements:
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to: our strategy and plans; the size and scope of our pivotal Phase 3 trial and its likelihood of success; the interpretation of clinical data generated in our open-label study; the timing of clinical results of the Cognition Maintenance Study; the treatment of Alzheimer’s disease dementia; the status of current and future clinical studies with simufilam, including anticipated patient enrollment goals in 2023 for our Phase 3 studies; the safety or efficacy of simufilam in patients; the release of evidential data by a third-party related to the biological activity of simufilam; the use of mass spectrometry as an alternative method of detection for SavaDx or the timing of new data release for SavaDx; expected cash use in future periods; verbal commentaries made by our employees; and potential benefits, if any, of the our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning.
Simufilam and SavaDx are investigational product candidates. They are not approved by any regulatory authority and their safety, efficacy or other desirable attributes have not been established in patients. All clinical data from our open-label study are inherently exploratory in nature and, as with all open-label data, should be interpreted with caution. Data results from our open-label study does not constitute, and should not be interpreted as, regulatory evidence of therapeutic safety or benefit for simufilam.
Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Clinical results and analyses of our open-label study should not be relied upon as predictive of Phase 3 studies or any other study. Our clinical results from earlier-stage clinical trials may not be indicative of full results or results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.
Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended
– Financial Tables Follow –
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended
|Research and development, net of grant reimbursement||$||17,652||$||10,342||$||68,032||$||24,813|
|General and administrative||3,285||4,102||11,988||8,055|
|Total operating expenses||20,937||14,444||80,020||32,868|
|Other income, net||249||258||997||434|
|Net loss per share, basic and diluted||$||(0.47||)||$||(0.35||)||$||(1.90||)||$||(0.82||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||40,775||39,960||40,202||39,405|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||201,015||$||233,437|
|Prepaid expenses and other current assets||10,211||11,045|
|Total current assets||211,226||244,482|
|Property and equipment, net||22,864||20,616|
|Operating lease right-of-use assets||122||210|
|Intangible assets, net||622||1,075|
|Liabilities and stockholders' equity|
|Accrued development expense||2,280||2,803|
|Accrued compensation and benefits||170||1,877|
|Operating lease liabilities, current||104||97|
|Other accrued liabilities||492||631|
|Total current liabilities||7,063||12,534|
|Operating lease liabilities, non-current||35||139|
|Other non- current liabilities||197||194|
|Common Stock and additional paid-in-capital||511,091||461,221|
|Total stockholders' equity||227,539||253,915|
|Total liabilities and stockholders' equity||$||234,834||$||266,782|
Source: Cassava Sciences, Inc.